Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Phenylephrine Hydrochloride Ophthalmic Solution
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Class II · Moderate risk
Dextroamphetamine Sacharate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class II · Moderate risk
Povidone Iodine
Lack of sterility assurance.
Class II · Moderate risk
Major Infants' Gas Relief Drops
Microbial Contamination of Non-Sterile Product.
Class II · Moderate risk
Lidocaine Hydroclhoride Jelly USP
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Class II · Moderate risk
Optiray 320
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class II · Moderate risk
Fentanyl Citrate USP
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Class II · Moderate risk
Isoproterenol HCL
Lack of Assurance of Sterility
Class II · Moderate risk
L-Asparaginase Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 9A/B Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 9 Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 5 B
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 10 D Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin 10 B Lyophilized
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
SUCCinylcholine Chloride
Lack of Assurance of Sterility